title: Long-term clearance of hepatitis C virus following interferon α-2b or peginterferon α-2b, alone or in combination with ribavirin.
abstract: Sustained virologic response (SVR) is the standard measure for evaluating response to therapy in patients with chronic hepatitis C (CHC). The aim of this study was to prospectively assess the durability of SVR in the pivotal studies of peginterferon (PEG-IFN) α-2b or IFN α-2b. We conducted two phase 3b long-term follow-up studies of patients previously treated for CHC in eight prospective randomized studies of IFN α-2b and/or PEG-IFN α-2b. Patients who achieved SVR [undetectable hepatitis C virus (HCV) RNA 24 weeks after completion of treatment] were eligible for inclusion in these follow-up studies. In total, 636 patients with SVR following treatment with IFN α-2b and 366 with SVR following treatment with PEG-IFN α-2b were enrolled. Definite relapse (quantifiable serum HCV RNA with no subsequent undetectable HCV RNA) was reported in six patients treated with IFN α-2b and three patients treated with PEG-IFN α-2b. Based on these relapses, the point estimate for the likelihood of maintaining response after 5 years was 99.2% [95% confidence interval (CI), 98.1-99.7%] for IFN α-2b and 99.4% (95% CI, 97.7-99.9%) for PEG-IFN α-2b. Successful treatment of hepatitis C with PEG-IFN α-2b or IFN α-2b leads to clinical cure of hepatitis C in the vast majority of cases.
authors.affiliation: Department of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Hannover, Germany. manns.michael@mh-hannover.de
authors.forename: M P
authors.initials: MP
authors.lastname: Manns
authors.forename: P J
authors.initials: PJ
authors.lastname: Pockros
authors.forename: G
authors.initials: G
authors.lastname: Norkrans
authors.forename: C I
authors.initials: CI
authors.lastname: Smith
authors.forename: T R
authors.initials: TR
authors.lastname: Morgan
authors.forename: D
authors.initials: D
authors.lastname: Häussinger
authors.forename: M L
authors.initials: ML
authors.lastname: Shiffman
authors.forename: S J
authors.initials: SJ
authors.lastname: Hadziyannis
authors.forename: W N
authors.initials: WN
authors.lastname: Schmidt
authors.forename: I M
authors.initials: IM
authors.lastname: Jacobson
authors.forename: R
authors.initials: R
authors.lastname: Bárcena
authors.forename: E R
authors.initials: ER
authors.lastname: Schiff
authors.forename: O S
authors.initials: OS
authors.lastname: Shaikh
authors.forename: B
authors.initials: B
authors.lastname: Bacon
authors.forename: P
authors.initials: P
authors.lastname: Marcellin
authors.forename: W
authors.initials: W
authors.lastname: Deng
authors.forename: R
authors.initials: R
authors.lastname: Esteban-Mur
authors.forename: T
authors.initials: T
authors.lastname: Poynard
authors.forename: L D
authors.initials: LD
authors.lastname: Pedicone
authors.forename: C A
authors.initials: CA
authors.lastname: Brass
authors.forename: J K
authors.initials: JK
authors.lastname: Albrecht
authors.forename: S C
authors.initials: SC
authors.lastname: Gordon
mesh_terms: D004359:Drug Therapy, Combination; D005500:Follow-Up Studies; D016174:Hepacivirus / Q000302:isolation & purification; D019698:Hepatitis C, Chronic / Q000188:drug therapy*; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000627:therapeutic use*; D011092:Polyethylene Glycols / Q000627:therapeutic use*; D011446:Prospective Studies; D012367:RNA, Viral / Q000097:blood; D011994:Recombinant Proteins / Q000627:therapeutic use; D012008:Recurrence; D012254:Ribavirin / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D000077190:Interferon alpha-2; D016898:Interferon-alpha; D012367:RNA, Viral; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; D012254:Ribavirin; C417083:peginterferon alfa-2b
keywords: clinical; cure; eradication; follow-up; longitudinal